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Regulatory Affairs Specialist

IrishJobs

Limerick, Wexford, Ireland

Limerick, Wexford, Ireland

Über

Main Duties: - Assist in the preparation, compilation and submission of premarket regulatory documentation, including EU IVDR submission, 510(k) submissions and other international filings, ensuring accuracy, completeness and adherence to regulatory requirements. - Review, maintenance and approval of technical documentation of the companys products, in compliance with the relevant regulations and standards. - Review complaints, CAPAs and non-conformances for regulatory reporting for CE-IVD marked products. - Assist in preparation, maintenance and approval of Risk Management and Post Market Surveillance Files. - Review and approval of artwork (labels, instructions for use) for compliance with applicable regulatory requirements and international standards. - Review change controls for impact on regulatory compliance. - Monitor changes in legislation, standards and guidance documents related to the companys products and communicate findings to cross functional teams as required. - Assist in distribution process to ensure regulatory compliance. - Support regulatory audits and inspections. - Maintain appropriate regulatory records. - Review and approve internal and external queries and requests. - Collaborate effectively with cross functional teams such as Quality and R&D to gather necessary information and align regulatory activities with product development milestones. Essential Criteria: - BSc in Molecular Biology or a relevant discipline. - Minimum 3 years' experience working in a regulatory role for a Medical Device or In Vitro Diagnostic Company. - Experience in reviewing and approving technical documentation as per EU/US regulations. - Good working knowledge of ISO 13485, ISO 14791 and IVDR/MDR. - Ability to manage competing priorities in a fast-paced environment. - Ability to work to tight deadlines - Good initiative and team player - Strong writing, verbal and interpersonal skills. Desirable Criteria: - Experience supporting product launches in new markets. - Experience in audits or inspections. - Experience in health authority interactions. Adecco Ireland is acting as an Employment Agency in relation to this vacancy.

TLNT1_IJ

Limerick, Wexford, Ireland

Sprachkenntnisse

English

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